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PMC’s Amy M. Miller: Ethically and Scientifically ‘No Going Back’

WASHINGTON (July 31, 2015)

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A new analysis from the Personalized Medicine Coalition (PMC) reveals that July was a record-breaking month for personalized medicine at FDA, with the agency approving four new indications for personalized medicine products. In the analysis, which was published on the Coalition’s blog, Education & Advocacy, PMC Executive Vice President Amy M. Miller, Ph.D., says the field is “turning a corner,” noting the implications of that for ongoing health care policy conversations, including the current debate on drug costs.

“Policymakers
throughout the health care system have to play catch up, because ethically and
scientifically there is no going back,” she writes.

The
blog explains that the successful month is only the latest development in a
clear trend for the field, as 20 percent of FDA’s 2014 approvals were
personalized medicines. Miller speculates that this percentage will be matched
or exceeded this year.

“I
encourage all the field’s stakeholders to work together toward ensuring that
personalized medicine makes us healthier, because, as FDA’s recent decisions
make clear, personalized medicine is no longer just a hypothetical paradigm,”
she writes.